AI-enabled
Regulatory Monitoring
AI-enabled
Regulatory Monitoring
AI-enabled
Regulatory Monitoring
We build your central
regulatory intelligence hub.
We build your central
regulatory intelligence hub.
We build your central
regulatory intelligence hub.
Trusted by over 100+ MedTech manufacturers, including
Trusted by over 100+ MedTech manufacturers, including
One Platform. Worldwide Coverage.
Monitor all your relevant standards, regulations, and guidances in one tool.
Built to accelerate your
literature research
Standards, Guidances & Regulations
Standards, Guidances & Regulations
Monitored for the MedTech industry globally, with no limitations.*
Monitored for the MedTech industry globally, with no limitations.*
Worldwide
*as long as they are publicly accessible
Built to accelerate your
literature research
Be certain that no regulatory changes are missed.
Be certain that no regulatory
changes are missed.
What Flinn Can
Do For You
MONITORING
MONITORING
Monitor all your normative documents.
Monitor all your normative documents.
Immediately see when a new version was released.
Filter smartly through using various parameters (e.g., your assigned devices).
ASSESSMENT
ASSESSMENT
Efficient AI-assistant impact assessment of every change.
Efficient AI-assistant impact assessment of every change.
Screen changes smoothly with a detailed gap analysis.
Receive suggestions on relevancy of the change specifically for medical device manufacturers.
Our time-saving features
Built to accelerate your change monitoring process
Built to accelerate your
literature research
AI Agent Impact Assessment of Regulatory Changes
Be informed if elements change and receive a compact overview of changes and potential impacts.
Full coverage of International and national Regulations, Guidelines, and Standards
Standards are monitored in their global, european and national version to keep track of geographic changes.
Complete Monitoring of Guidance Documents
Get notified about new IMDRF, GHTF, MEDDEV, and MDCG documents.
Broad List of Details
Have a complete summary of each element, such as date of publication, current activity status, geographical application and much more.
Recommendation of New Elements
Stay ahead by getting medical device industry specific new standards and regulations that might be of interest.
Broad List of Details
Have a complete summary of each element, such as date of publication, current activity status, geographical application and much more.
Recommendation of New Elements
Stay ahead by getting medical device industry specific new standards and regulations that might be of interest.
Change Descriptions & Impact Assessment
Full coverage of International and national Regulations, Guidelines, and Standards
Complete Monitoring of Guidance Documents
Broad List of Details
Recommendation of New Elements
Change Descriptions & Impact Assessment
Full coverage of International and national Regulations, Guidelines, and Standards
Complete Monitoring of Guidance Documents
Broad List of Details
Recommendation of New Elements
How accurate is Flinn?
How accurate
is Flinn?
We build our software to meet the accuracy standards of safety-critical, regulated environments.
We secure highest accuracy by:
Validating and releasing features carefully
Validating and releasing features carefully
Benchmarking models for every task
Benchmarking models for every task
Training on real-world medical data
Training on real-world medical data
Validating and releasing features carefully
New AI features are launched in isolated environments, reviewed by experts, tested with real users, and only integrated into live workflows once proven effective and trustworthy.
Benchmarking models
for every task
We benchmark state-of-the-art LLMs (e.g., OpenAI, Claude, and LLaMA) to select the best model for each use case. Performance is continuously monitored and models are updated to ensure high and consistent accuracy.
Training on real-world medical data
Our models are trained and validated on curated datasets built with medical experts, using real data from medical devices to ensure clinically relevant and reliable outputs.
Let us show you
Let our experts walk you through Flinn’s software, showcasing the features that matter most for your use case.
Let us show you
Let our experts walk you through Flinn’s software, showcasing the features that matter most for your use case.
Let us show you
Let our experts walk you through Flinn’s software, showcasing the features that matter most
for your use case.
Curious to learn more?
Check out our blog where we share more insights on how we use AI to make literature searches smarter, faster, and more reliable for MedTech teams.
Regulatory
7 Min.
7 Min.
MHRA’s Risk-Based PMS: What’s Actually New in Great Britain (since 16 June 2025)
MHRA’s Risk-Based PMS: What’s Actually New in Great Britain (since 16 June 2025)
Tibor Zechmeister
Oct 29, 2025
Regulatory
AI
6 Min.
6 Min.
FLARE Series (5/6): Required Sample Size – From Probability Theory to Practical Validation
FLARE Series (5/6): Required Sample Size – From Probability Theory to Practical Validation
Tibor Zechmeister
Oct 13, 2025
Regulatory
6 Min.
6 Min.
FLARE Series (4/6): From Overall Risk to Feature-Level Insight
FLARE Series (4/6): From Overall Risk to Feature-Level Insight
Tibor Zechmeister
Sep 15, 2025
Curious to learn more?
Check out our blog where we share more insights on how we use AI to make literature searches smarter, faster, and more reliable for MedTech teams.
Regulatory
7 Min.
MHRA’s Risk-Based PMS: What’s Actually New in Great Britain (since 16 June 2025)
Tibor Zechmeister
Oct 29, 2025
Regulatory
AI
6 Min.
FLARE Series (5/6): Required Sample Size – From Probability Theory to Practical Validation
Tibor Zechmeister
Oct 13, 2025
Regulatory
6 Min.
FLARE Series (4/6): From Overall Risk to Feature-Level Insight
Tibor Zechmeister
Sep 15, 2025
© 2025, 1BillionLives GmbH,
All Rights Reserved
© 2025, 1BillionLives GmbH,
All Rights Reserved
© 2025, 1BillionLives GmbH,
All Rights Reserved